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FDA 510(k)

FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE

K-Number: K965228 · 1997-11-10

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1997-11-10
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1997-11-10 under 510(k) number K965228. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE?

FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE is a medical device that received FDA 510(k) clearance on 1997-11-10. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K965228.

When did FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE receive FDA 510(k) clearance?

FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE received FDA 510(k) clearance on 1997-11-10, under 510(k) number K965228.

Who is the listed applicant for FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE?

The FDA product code for FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE is MAI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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